EUCTR2021-005611-31-PL招募中1 期
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Safety and Efficacy of CORT113176 (Dazucorilant) in Patients with Amyotrophic Lateral Sclerosis (DAZALS) - DAZALS
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 228
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male and female patients =18 years of age with ALS as defined by Gold Coast Criteria.
- •2. Patients with sporadic or familial ALS with a risk of ALS progression characterized by an ENCALS risk profile score = -6 and = -3.
- •3. Regulatory-authority-approved therapies for the treatment of ALS are permitted. If taking riluzole and/or edaravone, and/or sodium phenylbutryte and taurursodial, must have been on a stable dose of
- •riluzole for =30 days and/or edaravone for =60 days and/or sodium phenylbutyrate and taurursodial maintenance dosage =30 days prior to Screening.
- •4. Medically able to undergo the study procedures and to adhere to the visit schedule at the time of study entry, as determined by the Investigator.
- •5. Able to understand the purpose and risks of the study; willing and able to adhere to scheduled visits, treatment plans, laboratory tests, and other study evaluations and procedures.
- •6. Provide written informed consent for participation in the study.
- •7. Male patients and female patients of childbearing potential must agree to use a protocol-specified method of contraception from screening and during the study until 28 days after last dose of study drug.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 133
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 65
排除标准
- •1. History of a clinically significant non-ALS neurologic disorder, including, but not limited to, muscular dystrophy, spinal stenosis, peripheral neuropathy, inherited neuropathies, Alzheimer’s disease, cervical spondylosis, Parkinson’s disease, Lewy body dementia, vascular dementia, Huntington’s disease, epilepsy, stroke, multiple sclerosis, multifocal motor neuropathy, diabetic neuropathy, brain tumor, or brain infection/abscess.
- •2. Inability to swallow capsules.
- •3. Blood platelet count <150,000/mm3.
- •4. Renal impairment indicated by eGFR =30 mL/min/1.73m2.
- •5. Human immunodeficiency virus (HIV) or current chronic/active infection with hepatitis C virus or hepatitis B virus including patients with chronic or active hepatitis B as diagnosed by serologic tests.
- •6. Women who are pregnant, planning to become pregnant, or are breastfeeding. Women of childbearing potential who are unwilling or
- •unable to use highly effective method of contraception from screening through the duration of treatment and up to 28 days after last dose of
- •study drug.
- •7. Known liver impairment (Child-Pugh Class A, B, or C).
- •8. History of Class III/IV heart failure (per New York Heart Association).
- •9. At the time of Screening, any use of non-invasive ventilation (NIV), e.g., continuous positive airway pressure [CPAP], noninvasive bi-level positive airway pressure [NPPV] or noninvasive volume ventilation [NVV] for any portion of the day, or mechanical ventilation via tracheostomy, or on any form of oxygen supplementation.
- •10. Any form of cancer within the 5 years before first dose in this study (with the exception of basal cell and/or squamous cell cancer of the skin that has been treated completely and is without evidence of local recurrence or metastasis).
- •11. History of any other clinically significant cardiovascular, renal, hepatic, endocrine, metabolic, respiratory, gastrointestinal (GI), bleeding, autoimmune, neurological, psychiatric disorder, or unstable medical condition (other than ALS), as judged by the Investigator.
- •12. History and/or symptoms of adrenal insufficiency.
- •13. Abnormal liver function defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 × upper limit of normal (ULN).
- •14. QTcF interval based on the mean of 2 ECGs of >450 ms, for men and >470 ms for women.
- •15. History of additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia, family history of long-QT syndrome).
- •16. Positive nasopharyngeal PCR test for SARS-CoV-2 on Day -1 or within 8 weeks prior to Screening.
- •17. Ongoing use of any strong CYP3A4 inhibitor/inducer or any medication with a narrow therapeutic index that is predominantly metabolized by CYP2C8.
- •18. Taking, or have taken, any strong CYP3A inducer within 30 days (or 5 half-lives if longer) before Screening, or any strong CYP3A inhibitor within 14 days before Screening.
- •19. Current or anticipated need, in the opinion of the Investigator, of a diaphragm pacing system (DPS) during the study period.
- •20. Received any live or attenuated vaccine within 30 days, before the first dose of study drug. Exceptions may apply on a case-by-case basis, if considered not to interfere with the objectives of the study, as agreed by the PI and the Corcept Medical Monitor.
- •21. Currently using glucocorticoids or have a history of regular systemic glucocorticoid use at any dose within the last 12 months or 3 months for inhaled products before first dose of study drug. (Patients who have stopped glucoco
研究者
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